Cell-free DNA Methylation for Endometrial Cancer

Not Applicable

• Conditions: DNA Methylation; Training Set; Cervical Cytology; Diagnostic Accuracy; Validation Set; Endometrial Cancer; Liquid Biopsy
• Interventions: Diagnostic Test: DNA methylation testing

• Registration Number: NCT04651738
• Lead Sponsor: Lei Li

Brief Summary

Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.

In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.

In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.

In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Status Verified: 2020-12
• Study First Posted: 2020-12-03
• Last Update Submitted: 2020-12-17
• Study Start: 2020-12-18
• Last Update Posted: 2020-12-21
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
• With sufficient fresh peripheral serum, cervical cytology, and endometrial samples for DNA methylation testing before with or without after major surgeries.
• Aged 18 years or older.
• Signed an approved informed consents

Exclusion Criteria

• Not meeting all of the inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	DNA methylation testing	All eligible participants consenting to participate the study.

Primary Outcome Measures

Name	Time	Method
Cut-off values of targeted DNA methylation in endometrial cancer	Two years	The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients

Secondary Outcome Measures

Name	Time	Method
Accuracy of serum DNA methylation in endometrial cancer	Two years	The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China